STAT PROFILERecalls & reported problems across all models
Nova Biomedical Corporation · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one STAT PROFILE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 93
- Deaths reported
- 2
- Injuries reported
- 1
- Recalls
- 1
We found 13 models of STAT PROFILE by Nova Biomedical Corporation in the FDA's device registry (GUDID). Together they are named in 93 adverse event reports in the FDA's MAUDE database, received between Apr 11, 2017 and May 21, 2026 — classified as 2 deaths, 1 injury, 90 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (22 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
STAT PROFILE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 18, 2023Open, Classified
Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.
Z-0207-2024 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗
Most reported STAT PROFILE problems
Device problems
- Low Test Results22
- Incorrect Measurement17
- Incorrect, Inadequate or Imprecise Result or Readings17
- High Test Results14
- Imprecise or Erratic Results14
- Misassembly During Maintenance/Repair14
- Failure to Calibrate6
- Smoking3
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- No Known Impact Or Consequence To Patient19
- No Consequences Or Impact To Patient17
- Insufficient Information5
- No Information3
- Aneurysm1
- Burn(s)1
- Cardiac Arrest1
STAT PROFILE models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stat Profile Prime PlusElectrode measurement, blood-gases (pco2, po2) and blood ph1 recall1 death50 reports
- Stat Profile Prime PlusElectrode measurement, blood-gases (pco2, po2) and blood ph1 recall0 reports
- STAT PROFILE PHOX ULTRA CO OXTEST, LACTIC ACID, OVER THE COUNTER14 reports
- STAT PROFILE PHOX ULTRAELECTRODE, ION SPECIFIC, CALCIUM8 reports
- STAT PROFILE PRIME CCS COMPCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)1 death7 reports
- STAT PROFILE PRIME CCS COMPELECTRODE, ION SPECIFIC, CALCIUM5 reports
- STAT PROFILE Prime CCS CompELECTRODE, ION SPECIFIC, CALCIUM3 reports
- STAT PROFILE CCXELECTRODE, ION-SPECIFIC, CHLORIDE1 report
- STAT PROFILE CCX CO OXCONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)1 report
- STAT PROFILE PRIME CCSINSTRUMENT, HEMATOCRIT, AUTOMATED1 report
- STAT PROFILE PRIME CSSELECTRODE, ION-SPECIFIC, CHLORIDE1 report
- STAT PROFILE PRIME CCSINSTRUMENT, HEMATOCRIT, AUTOMATED1 report
- Stat Profile Prime PlusElectrode measurement, blood-gases (pco2, po2) and blood ph1 report
Recent STAT PROFILE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Failure to Calibrate
CUSTOMER SAID CARD HAS BEEN READING 0% SINCE (B)(6) 2026. THEY HAVE NOT BEEN ABLE TO RUN ANY SAMPLES SINCE (B)(6) 2026 AND DID NOT HAVE A BACKUP SENSOR CARD. A PATIENT WAS REROUTED BECAUSE THE SENSOR CARD COULD NOT BE BROUGHT UP TO USE OR REPLACED.
Patient problems: Insufficient Information
MAUDE report 25243493 ↗MalfunctionMar 11, 2026Failure to Prime
PER CUSTOMER: "I AM WRITING TO REPORT THAT OUR NOVA STAT PROFILE PRIME PLUS WAS COMPLETELY NONFUNCTIONAL TODAY, WHICH SIGNIFICANTLY IMPACTED PATIENT TESTING AND WORKFLOW IN OUR LABORATORY. THIS DOWNTIME DIRECTLY AFFECTED PATIENT CARE. WE HAD A STAT PATIENT WITH SUSPECTED HYPERKALEMIA, AND WE WERE UNABLE TO PROVIDE CRITICAL POTASSIUM RESULTS TO THE PROVIDER DUE TO THE INSTRUMENT FAILURE. THIS SITUATION POSED A SERIOUS RISK TO TIMELY CLINICAL DECISION-MAKING." A FOLLOW UP WITH THE CUSTOMER INDICATED THE ANALYZER HAD BEEN DOWN ALL DAY AND AFTER CONSUMABLES WERE REPLACED THE ANALYZER HAS BEEN BUSY PRIMING/CALIBRATING AND MOST OF THE TEST ARE LOCKED OUT. THE AUDIT LOG INDICATED SLOPE ERRORS ON SEVERAL PARAMETERS.
Patient problems: Hyperkalemia
MAUDE report 24570256 ↗MalfunctionFeb 12, 2026Failure to Calibrate; Calibration Problem
CONSUMER REPORTED THAT THEY HAVE BEEN HAVING ISSUES WITH THE ANALYZER STAYING CALIBRATED FOR PO2 AND HAVE CONSISTENTLY NEEDED TO REPLACE THE CONSUMABLES.THE CONSUMER REQUESTED SERVICE DUE TO INCONSISTENCY WITH CALIBRATION.
Patient problems: Insufficient Information; Ventilator Dependent
MAUDE report 24321484 ↗MalfunctionDec 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2025 THE CUSTOMER RAN PATIENT SAMPLES FOR PH AND HCO3 (BICARBONATE). THEY BELIEVED THE RESULTS THEY RECEIVED WERE INACCURATE AND RETESTED ANOTHER SAMPLE ON A DIFFERENT ANALYZER (ISTAT). THERE WAS SIGNIFICANT DISCREPANCY BETWEEN THE 2 ANALYZERS. IT IS UNCLEAR HOW MUCH TIME HAD PASSED BETWEEN THE RETESTING OF THE SAMPLE. ALTHOUGH THERE WAS NO REPORTED TREATMENT TO THE PATIENT BASED ON THE ALLEGED INACCURATE RESULTS, THE CUSTOMER CLAIMED THAT THERE COULD HAVE BEEN AN ADVERSE EVENT HAD THEY TREATED BASED ON THOSE RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830129 ↗MalfunctionMay 2, 2025Low Test Results; Low Test Results
SODIUM RESULT INCOMPATIBLE WITH THE PATIENT'S CLINICAL DATA.
Patient problems: Heart Failure/Congestive Heart Failure; Renal Failure
MAUDE report 21952903 ↗DeathOct 22, 2024Low Test Results; Low Test Results
ON (B)(6) 2024 PATIENT WAS ADMITTED WITH AN ANEURYSM AND UNDERWENT CARDIAC SURGERY TO PLACE VALVES (UNSPECIFIED). LOW PCO2 RESULT INCOMPATIBLE WITH THE PATIENT'S CLINIC. PATIENT EXPIRED THURSDAY EVENING (B)(6) 2024.
Patient problems: Aneurysm
MAUDE report 20511410 ↗InjuryDec 9, 2022Inability to Irrigate; Inability to Irrigate
THE OPERATOR OF THE DEVICE SUSTAINED EYE EXPOSURE TO FLUSH FLUID WHEN ATTEMPTING TO CLEAR A VISIBLE CLOT IN THE PROBE OF THE ANALYZER. THE OPERATOR WAS NOT WEARING EYE PROTECTION.
Patient problems: Exposure to Body Fluids
MAUDE report 15952812 ↗MalfunctionNov 15, 2022Low Readings; Low Readings
CUSTOMER REPORTS DISCREPANCIES IN HB RESULTS FOR ONE PATIENT.
Patient problems: Pulmonary Dysfunction
MAUDE report 15799839 ↗MalfunctionJul 15, 2022No Apparent Adverse Event; No Apparent Adverse Event
COMPLAINANT REPORTED SUSPECT ERROR PROBLEMS OVER THE WEEKEND OF (B)(6) 2022 WHICH RESULTED IN A DELAY OF CARE FOR A PATIENT IN THE NEONATAL UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15033007 ↗MalfunctionJul 7, 2022Incorrect Measurement; Incorrect Measurement
NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF BICARBONATE (HCO3) AND BASE EXCESS OF BLOOD (BE-B) RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED BUT THE CLINICIAN QUESTIONED THE ACCURACY OF THESE WHEN COMPARED TO THE CLINICAL PRESENTATION OF THE PATIENT. AN ADDITIONAL SAMPLE FROM THE PATIENT WAS RUN USING THE REFERENCE EPOC ANALYZER WHICH CONFIRMED THE INITIAL RESULTS WERE INACCURATE. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 14944310 ↗MalfunctionJul 7, 2022Incorrect Measurement; Incorrect Measurement
NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING ANALYSIS OF SODIUM, POTASSIUM, CHLORIDE, AND BLOOD UREA NITROGEN (BUN) RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME PLUS ANALYZER WITH SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED BUT THE CLINICIAN QUESTIONED THE ACCURACY OF THESE WHEN COMPARED TO THE CLINICAL PRESENTATION OF THE PATIENT. AN ADDITIONAL SAMPLE FROM THE PATIENT WAS RUN USING THE REFERENCE ANALYZER BECKMAN AU WHICH CONFIRMED THE INITIAL RESULTS WERE INACCURATE. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 14944290 ↗MalfunctionMay 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT THEIR PHOX ULTRA ANALYZER, SERIAL NUMBER (B)(4) GAVE A CRITICAL LOW ICA RESULT FOR A PATIENT. THE TEST WAS RUN ON (B)(6) 2022 USING ICA SENSOR LOT NUMBER 22033023. WHEN SAME SAMPLE WAS REPEATED ON A DIFFERENT PHOX ULTRA, THE RESULT WAS NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14476543 ↗MalfunctionApr 5, 2022Incorrect Measurement; High Test Results; No Apparent Adverse Event; Incorrect Measurement; High Test Results; No Apparent Adverse Event
NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING PCO2 RESULTS DURING THE TREATMENT OF A PATIENT ON A STATPROFILE PRIME CCS COMP ANALYZER WITH SERIAL NUMBER (B)(4). THE USER DID NOT BELIEVE THE RESULTS PRODUCED WERE ACCURATE AND QUESTIONED THE RESULTS BEFORE PROVIDING ANY TREATMENT. THE SAME SAMPLE WAS RUN ACROSS ANOTHER STATPROFILE PRIME PLUS CCS COMP ANALYZER WHICH CONFIRMED THE INITIAL RESULTS WERE INCORRECT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014864 ↗MalfunctionApr 5, 2022Low Test Results; Low Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014720 ↗MalfunctionApr 5, 2022Low Test Results; Low Test Results
THE CUSTOMER IS REPORTING VARIABLE RESULTS FOR PCO2 ON THEIR PRIME ANALYZER. NO PATIENT HARM OR INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014669 ↗
Other Nova Biomedical Corporation products
All Nova Biomedical Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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